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Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement

Primary Purpose

Cancer Pain, Breakthrough Pain

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Intravenous Infusion

Sublingual Tablet

About this trial

This is an interventional treatment trial for Cancer Pain

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 19-80
Cancer pain
Admission for the control of cancer pain or consultation for the treatment of cancer pain
Stable vital sign
ECOG status ≤ 3 for more than 1 or 2 months
Opioid-tolerant state
No history of using sublingual fentanyl

Exclusion Criteria:

Noncancer pain
Opioid naive
baseline NRS pain score> 4
Current using sublingual fentanyl
Difficult to assess cancer pain
no evidence of disease(cancer)
Planned surgical resection of cancer
Allergy to fentanyl
Severe renal and/or liver function
Severe respiratory depression or uncontrolled COPD

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

IV PCA (proportional dosage)

SL-FTN (equivalent dose for PCA bolus)

Arm Description

Breakthrough pain control by bolus based IV patient-controlled anagesia Fentanyl bolus = MME * 15%

Breakthrough pain control by sublingual fentanyl Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement.

Outcomes

Primary Outcome Measures

Change in 11-point scale NRS pain score

Change in pain score compared to baseline Score '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"

Secondary Outcome Measures

Change in 11-point scale NRS pain score

sum of pain intensity difference(SPID)

sum of pain intensity change compared to baseline difference

number of additional doses

number of additional doses fentanyl bolus or subligual

Pain interference

Pain interference using BPI-SF

Insomnia

The severity of insomnia using ISI

Depression

The severity of depression using Beck Depression Inventory(BDI) 1-10: These ups and downs are considered normal 11-16: Mild mood disturbance 17-20: Borderline clinical depression 21-30: Moderate depression 31-40: Severe depression over 40: Extreme depression

Satisfaction scale

Satisfaction check using 5 Likert-scale (1) Very dissatisfied; (2) Not satisfied; (3) Neutral; (4) Satisfied; (5) Very satidfied

Full Information

NCT ID

NCT05053308

First Posted

August 30, 2021

Last Updated

August 3, 2023

Sponsor

Seoul National University

1. Study Identification

Unique Protocol Identification Number

NCT05053308

Brief Title

Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement

Official Title

Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement Versus Intravenous PCA for Breakthrough Cancer Pain: A Prospective, Randomized, Open Label, Non Inferiority Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Withdrawn

Why Stopped

The supply of IP is disrupted

Study Start Date

December 1, 2022 (Anticipated)

Primary Completion Date

May 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Proportional dose of sublingual fentanyl tablet (Narco®) based on daily opioid requirement versus intravenous PCA for breakthrough cancer pain: A prospective, randomized, open-label, noninferiority trial.

Detailed Description

Based on the previous around-the-clock analgesic demand compared to IV PCA in cancer pain patients to prepare the basis for the administration of fentanyl sublingual tablets with an initial dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer Pain, Breakthrough Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IV PCA (proportional dosage)

Arm Type

Active Comparator

Arm Description

Breakthrough pain control by bolus based IV patient-controlled anagesia Fentanyl bolus = MME * 15%

Arm Title

SL-FTN (equivalent dose for PCA bolus)

Arm Type

Experimental

Arm Description

Breakthrough pain control by sublingual fentanyl Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement.

Intervention Type

Drug

Intervention Name(s)

Intravenous Infusion

Other Intervention Name(s)

PCA

Intervention Description

IV PCA(fentanyl) Fentanyl bolus = MME * 15%

Intervention Type

Drug

Intervention Name(s)

Sublingual Tablet

Other Intervention Name(s)

sublingual

Intervention Description

subligual fentanyl(Narco®) Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement.

Primary Outcome Measure Information:

Title

Change in 11-point scale NRS pain score

Description

Time Frame

30 minutes after administration

Secondary Outcome Measure Information:

Title

Change in 11-point scale NRS pain score

Description

Time Frame

15, 45, 60 minutes after administration

Title

sum of pain intensity difference(SPID)

Description

sum of pain intensity change compared to baseline difference

Time Frame

60 minutes after administration

Title

number of additional doses

Description

number of additional doses fentanyl bolus or subligual

Time Frame